FDA Denies Citizen Petition Seeking Ban on Phthalates

For the second time in as many years, federal regulators have rejected calls to ban some phthalates from use in U.S. food products, despite health concerns linking the chemicals to preterm births, heart-related deaths, and brain development disorders.

The U.S. Food and Drug Administration (FDA) issued a final response letter (PDF) to the environmental group Earthjustice last week, announcing it has rejected a citizens petition by the group to ban eight types of phthalates from use in U.S. foods. It is the second time the agency has rejected the petition.

Phthalates include a group of chemicals used to make plastics more durable and dissolve other materials. They are commonly found in a wide range of items ranging from vinyl flooring, soaps, shampoos, hair sprays and cosmetics, but have also been used in food containers.

In April 2016, Earthjustice joined together with other environmental and consumer advocacy groups to petition the FDA to prohibit the use of eight ortho-phthalates, more commonly known as just phthalates, in U.S. foods, including: diisobutyl phthalate, di-n-butyl phthalate, butyl benzyl phthalate, dicyclohexylphthalate, di-n-hexyl phthalate, diisooctyl phthalate, di(2-ethylhexyl) phthalate, and diisononyl phthalate.

The petition said the FDA failed to consider the hazards of exposure to the chemicals to humans. The chemicals are often found in the lining of canned goods, plastic for water bottles, food containers, and even cash register receipts.

FDA Rejects Phthalates Ban for the Second Time

The FDA rejected that petition in May 2022, which led to the group submitting another petition to reconsider the ruling in June 2022. However, at the time the agency did agree to revoke food contact uses of 23 phthalates and two other substances used as plasticizers, adhesives, defoaming agents, surface lubricants, resins, and slimicides. This FDA’s action removed those phthalates from the list of substances authorized by its regulations in 21 CFR parts 175 through 178.

The updated petition urged reconsideration of additional chemicals. The FDA also rejected that call for reconsideration.

The FDA indicates four criteria must be met for the agency to reconsider a ruling, including a demonstration that information in the administrative record was not fully considered, that the petitioner’s position is not frivolous, that there are grounds for reconsideration, and that reconsideration is not outweighed by public health or public interests.

In this case, the FDA determined the four criteria were not met, noting that just because a clinical study identified a “possible effect” a chemical may have on the human body, that does not mean the chemical is unsafe under the intended conditions of use approved by the FDA.

“In sum, we concluded that the administrative record, which included the information contained in and relied upon by your Original Petition as well as the information contained in and relied upon by your Food Additive Petition, did not set forth a sufficient showing that the scientific evidence supports amending our regulations to prohibit the use of these substances,” the FDA wrote in its response. “Specifically, we concluded that the administrative record did not support a determination that any amount of the substances caused food to be adulterated.”

Earthjustice blasted the FDA’s decision in a July 21 press release, saying the agency is not doing its job in protecting public health.

“There is overwhelming evidence that phthalates in our food cause life-altering damage to people’s health, including the health of babies and young children,” Earthjustice Attorney Katherine O’Brien said in the press release. “Rather than fulfill its duty to protect public health from this toxic exposure, FDA has wasted years on delay tactics while both the evidence of phthalates’ toxic effects and the human health toll continue to grow.”

Phthalate Health Risks

Many health experts have raised concerns about the presence of phthalates in food and other products.

The chemicals are known to disrupt hormones and affect human health. Phthalate side effects have been linked to reproductive problems, increasing a woman’s chance of fibroids and endometriosis and miscarriage. Studies have also linked the chemicals to lower IQ in children if exposed during pregnancy, as well as reduced male fertility.

Prior studies have identified risks from phthalate exposure prior to conception, finding that it may increase the risk of preterm birth by up to 70%. Additionally, exposure to phthalates is linked to other health side effects, including heart-related deaths. Phthalate exposure increased the risk of heart complications and morality rates. More so, other research has linked phthalate exposure to brain development disorders.

Hair Relaxer Cancer Risks Linked to Phthalates and Other Endocrine Disrupting Chemicals

Over the past six months, concerns about hair relaxer cancer risks have emerged in multiple peer reviewed medical journals, indicating that exposure to phthalates, formaldehyde and thousands of potentially harmful chemicals in hair straightening products may cause uterine cancer, endometrial cancer, ovarian cancer and other injuries.

As a result of the risk, there are now growing number of hair relaxer lawsuits are now being pursued by women nationwide in recent months, each involving allegations that manufacturers put their desire for profits ahead of the safety and health of women of color, by failing to disclose that phthalates in hair straighteners may increase the risk of endometrial cancer, uterine cancer, ovarian cancer, fibroids and other side effects.

Lawsuits over the link between cancer and hair relaxers began to emerge late last year, after the publication of a study in the Journal of the National Cancer Institute, which highlighted the substantial risk women have been exposing themselves to wen using products like Dark & Lovely, Optimum and other chemical hair relaxers.

In findings published in October 2022, researchers from the National Institute of Environmental Health reviewed data on nearly 34,000 women in the United States between the ages of 35 and 74, who completed questionnaires on their use of multiple hair products, including hair dyes, straighteners, relaxers, or pressing products, and permanents or body waves. A 10 year follow-up on the incident rate of uterine cancer diagnosis was performed, and researchers reported that women who used hair relaxers at least four times per year faced a 156% increased risk of developing uterine cancer.

The lawsuits have been consolidated as part of a federal multidistrict litigation (MDL) before U.S. District Judge Mary M. Rowland in the Northern District of Illinois. Given common questions of fact and law raised in the lawsuits, Judge Rowland is working with the parties to establish a schedule for coordinated discovery and determining when a series of early bellwether trials may be ready to begin.

As part of the coordinated management of the litigation, it is expected that Judge Rowland will establish a bellwether process, where small groups of representative injury claims will go through case-specific discovery and be prepared for early trial dates, to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.